Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel

"Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel in Stage II or Stage III Periodontitis: A Randomized Controlled Clinical Trial With Biochemical Analysis"

The goal of this clinical trial is to compare the efficacy of Noisome as carrier of minocycline hydrochloride gel to minocycline hydrochloride in Stage II or Stage III Periodontitis . The main questions it aims to answer are:

• Is the Noisome carrier of minocycline hydrochloride has an effect in comparing to minocycline hydrochloride in Stage II or Stage III Periodontitis?
• what is the release profile of of minocycline hydrochloride noisome gel and minocycline hydrochloride gel? Participants will be asked to maintain oral hygiene after application of treatment Researchers will compare the effect of noisome as a carrier of locally delivered minocycline hydrochloride gel to minocycline hydrochloride gel in stage II or stage III periodontitis patients as an adjunct to non-surgical periodontal treatment] to see if Plaque Index (PI) , Gingival index,Clinical attachment level (CAL) &Periodontal Pocket Depth decreased or not.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Minocycline hydrochloride with noisome carrier; Drug: Minocycline Hydrochloride only

Detailed Description

This study is designed to be a Randomized, Controlled, blinded, clinical trial; the eligible participants will be randomly allocated for one of the two comparative parallel-Groups; test and control group . The interventions will be prepared by the pharmacist and coded and the whole-time frame for the study will be 18 weeks.

The intervention to all participants will be Non-surgical debridement the the test group will receive the Noisome minocycline hydrochloride & control group will receive minocycline hydrochloride.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Israa Said, B.D.S; Phone Number: +201096872828; Email: israasaiid94@gmail.com
• Study Contact Backup: Name: Asmaa Zayan, MS; Phone Number: +201012003865; Email: asmaazaya810@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Ainshams university
    • Contact: Israa Said, B.D.S; Phone Number: +201096872828; Email: israasaiid94@gmail.com
    • Contact: Asmaa Zayan, MS; Phone Number: +201096872828; Email: asmaazaya810@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
• Generalized Periodontitis (Stage II or stage III ) Patients; ( ≥ 3 mm CAL, PD 5-7 mm ) , premolar-molar area (test site) .
• Having more than 16 tooth excluding wisdom and test teeth that still had both mesial and distal neighboring teeth.
• Systemically free according to the modified Burkitt's health history questionnaire

Exclusion Criteria:

• Non-surgical periodontal therapy within the previous 12 months, systemic or local use of antibiotics with the previous 3 months, medication with possible influence on the periodontium.
• Pregnancy or contraceptives usage.
• Breastfeeding.
• Known allergy to the ingredients of the treatment.
• Smokers.
• vulnerable group; prisoners & orphans .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minocycline hydrochloride with noisome as carrier; Group I ( Minocycline hydrochloride with noisome carrier) 15 patients will receive the drug ( Minocycline hydrochloride with noisome carrier gel) at intervals 1,3,7&14 days	Drug: Minocycline hydrochloride with noisome carrier; patient will receive Non-surgical debridement followed by injection of local delivery drug in the deepest pocket site, This will be done one day, three days, seven days and fourteen days
Active Comparator: Minocycline hydrochoride only; Group II (Minocycline hydrochloride only) 15 patients will receive the drug (Minocycline hydrochloride only gel) at intervals 1,3,7&14 days	Drug: Minocycline Hydrochloride only; patient will receive Non-surgical debridement followed by injection of local delivery drug in the deepest pocket site, This will be done one day, three days, seven days and fourteen days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure clinical assessment Plaque Index (PI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)	To measure the clinical parameter Plaque Index (PI) on score from zero to three 0 = No plaque in gingival area.; = A film of plaque adhering to the free gingival margin and adjacent area of tooth. The plaque may be recognized only by running a probe across the tooth surface.; = Moderate accumulation of soft deposit within the gingival pocket and on the gingival pocket and on the gingival margin and/or adjacent tooth surface that can be seen by naked eye.; = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.	measured at the baseline, before the application of drug& after 18 weeks
To measure clinical assessment Gingival Index (GI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)	To measure the clinical parameter gingival Index(GI) on score from zero to three Gingival index (GI) 0 = Normal gingiva.; = Mild inflammation, slight change in color, slight edema; no bleeding on probing.; = Moderate inflammation, redness, edema, and glazing; bleeding on probing.; = Sever inflammation, marked redness and edema, ulceration; tendency to spontaneous bleeding.	measured at the baseline, before the application of drug& after 18 weeks
To measure Clinical attachment level (CAL) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)	To measure Clinical attachment level (CAL) in millimeter (mm).	measured at the baseline, before the application of drug& after 18 weeks
To measure Periodontal Pocket Depth (PPD) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)	To measure Periodontal Pocket Depth (PPD) in millimeter (mm).	measured at the baseline, before the application of drug& after 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Evaluate the releasing profile of minocycline hydrochloride noisome gel and minocycline hydrochloride gel	change in number of releasing profile of each drug	first day then third day then seventh day lastly after fourteen days

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: faculty of pharmacy Tanta University
• Investigators: Study Director: Yasmin Fouad, PHD, Ainshams university

Publications and helpful links

General Publications

• Jain R, Mohamed F, Hemalatha M. Minocycline containing local drug delivery system in the management of chronic periodontitis: A randomized controlled trial. J Indian Soc Periodontol. 2012 Apr;16(2):179-83. doi: 10.4103/0972-124X.99259.
• Apatzidou DA, Kinane DF. Nonsurgical mechanical treatment strategies for periodontal disease. Dent Clin North Am. 2010 Jan;54(1):1-12. doi: 10.1016/j.cden.2009.08.006.
• Cortelli JR, Querido SM, Aquino DR, Ricardo LH, Pallos D. Longitudinal clinical evaluation of adjunct minocycline in the treatment of chronic periodontitis. J Periodontol. 2006 Feb;77(2):161-6. doi: 10.1902/jop.2006.040409.
• Nakao R, Takigawa S, Sugano N, Koshi R, Ito K, Watanabe H, Senpuku H. Impact of minocycline ointment for periodontal treatment of oral bacteria. Jpn J Infect Dis. 2011;64(2):156-60.
• Uchegbu IF, Vyas SP (2015). Non-Ionic surfactant based vesicles (noisome) in drug delivery. Int J Pharm. ;172:33-70.
• Williams RC, Paquette DW, Offenbacher S, Adams DF, Armitage GC, Bray K, Caton J, Cochran DL, Drisko CH, Fiorellini JP, Giannobile WV, Grossi S, Guerrero DM, Johnson GK, Lamster IB, Magnusson I, Oringer RJ, Persson GR, Van Dyke TE, Wolff LF, Santucci EA, Rodda BE, Lessem J. Treatment of periodontitis by local administration of minocycline microspheres: a controlled trial. J Periodontol. 2001 Nov;72(11):1535-44. doi: 10.1902/jop.2001.72.11.1535.

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2024
• Primary Completion (Estimated): May 25, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Minocycline hydrochloride
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: FDASU-RecIM022002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: sharing the inclusion& exclusion criteria , study design, intervention ,statistical data &references.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No